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12-06-2011 | Cardiology | Article

No cancer risk with ARBs, FDA concludes


US FDA Safety Communication

MedWire News: The US Food and Drug Administration (FDA) has concluded that there is no increased risk for cancer associated with ARB use, after conducting a safety review of the drug class.

The FDA undertook the review in the wake of a meta-analysis published by Ilke Sipahi (University Hospitals Case Medical Center, Ohio, USA) and colleagues.

Sipahi and team's analysis included 62,000 patients from five randomized clinical trials, and showed a small, but statistically significant, increased risk for cancer in patients taking an ARB compared to patients not taking an ARB.

The FDA review comprised a meta-analysis of 31 clinical trials in which 84,461 patients were randomized to ARB treatment and 71,355 patients to non-ARB treatment. They were followed up for an average of 39 months.

The review evaluated incident cancer, including breast, lung and prostate cancers, and cancer-related mortality in patients taking ARBs compared with patients taking non-ARB drugs.

The findings showed that the rate of incident cancer events was 1.82 per 100 patient-years in the ARB group compared with 1.84 per 100 patient-years in the non-ARB comparator group. The relative risk (RR) for incident cancer in patients taking ARBs was 0.99, demonstrating no significant difference between the two groups.

The lack of a difference between the two groups was maintained regardless of which statistical method was used, or whether the non-ARB comparator patients were taking placebo or another drug.

Further analysis showed no association between ARBs and cancer-related mortality (RR=1.04), breast cancer (odds ratio [OR]=1.06), lung cancer (OR=1.07), or prostate cancer (OR=1.05).

"This is the largest evaluation of such data to date," commented Mary Southworth (FDA's Center for Drug Evaluation and Research) in a press statement. "It finds no evidence of an increased risk of cancer in patients who take an ARB."

MedWire ( is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

By Piriya Mahendra

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